FDA Inspection 844449 — Vitamins Direct (USA), Inc.
The FDA completed an inspection of Vitamins Direct (USA), Inc. on August 14, 2013 in West Palm Beach, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 14, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Pesticides and Chemical Contaminants
- Location
- West Palm Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16058 | 21 CFR 111.535(b)(2) | Records - ret'nd dietary supplement: material review, dispos |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |